The Food and Drug Administration (FDA) has provided emergency use authorization to the first COVID-19 breath diagnostic test.
The test, developed by InspectIR, can tell whether someone has contracted COVID-19 by analyzing breath samples. It is not an at-home test, meaning authorized personnel must administer the breath test at a hospital, doctor’s office, or mobile COVID-19 testing site.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the approval of the device is “another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
The FDA is continuing to monitor emerging and advancing technologies that can “help address the current pandemic and better position the U.S. for the next public health emergency,” Shuren added.
According to the FDA, the test has a 91.2% sensitivity for positive results and a 99.3% sensitivity for negative results.
According to USA Today, the breathalyzer test works by having a patient exhale into a tube, like blowing up a balloon or an air-filled flotation device. Results are produced within three minutes.
Using “gas chromatography gas mass-spectrometry (GC-MS)” Inspect IR’s COVID-19 Breathalyzer is able “to separate and identify chemical mixtures” and quickly “identify five Volatile Organic Compounds (VOCs)” that can accurately determine a positive COVID-19 diagnosis.
InspectIR expects to produce 100 instruments per week and says using its breathalyzer method it can “evaluate approximately 160 samples per day.” Taking into account that level of production, InspectIR estimates that its testing capacity will increase by 64,000 samples per month.
Regardless of how accurate a test is, the FDA always recommends confirming positive results with a PCR test.